FDA

News and Updates by the Food and Drugs Administration (FDA)

Exelixis Shares Latest sNDA Progress for Cabozantinib in Treating Advanced Neuroendocrine Tumors

Exelixis, an innovative leader in oncology striving to revolutionize cancer care with next-gen therapies, recently announced that the United States Food and Drug Administration (FDA) has confirmed their supplemental New Drug Application (sNDA) for Cabozantinib (Cabometyx) will be reviewed at

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Phase 2 Study of Utreloxastat for ALS Patients by PTC Therapeutics Does Not Achieve Primary Goals

PTC Therapeutics, Inc., an international biopharmaceutical company dedicated to the innovation, development, and marketing of clinically unique medicines, announced that the phase 2 CardinALS study, a global and placebo-controlled trial, failed to meet its main goal of slowing ALS disease

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Lexicon Completes Enrollment for Phase 2B PROGRESS Trial of LX9211 in Diabetic Peripheral Neuropathic Pain

Lexicon Pharmaceuticals, a biopharmaceutical entity dedicated to developing transformative medicines, has finalized the patient enrollment process for their PROGRESS study. This Phase 2b trial evaluates LX9211, an innovative orally-administered selective small molecule inhibitor targeting adaptor-associated kinase 1 (AAK1), specifically for

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VectorBuilder and Sartorius Sign Agreement to Drive Biopharmaceutical Advancements

**VectorBuilder**, renowned for its comprehensive gene delivery services, and **Sartorius**, a prominent international partner in life sciences and biopharmaceuticals, have formalized a strategic collaboration agreement. This partnership aims to enhance gene vector and mRNA bioprocess services, expediting innovative biopharmaceutical projects

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Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan Granted Marketing Authorization by China NMPA for Advanced TNBC Treatment

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a subsidiary under Kelun Pharmaceutical, renowned for its dedication to the research, development, production, commercialization, and international partnership of novel biological and small molecule pharmaceuticals, has announced its receipt of marketing approval in China from

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Kisqali by Novartis Gains Broader EU Approval for High-Risk HR+/HER2- Early Breast Cancer Patients

Novartis revealed that the European Commission has endorsed Kisqali (ribociclib) alongside an aromatase inhibitor for the adjuvant management of hormone receptor (HR)-positive, HER2-negative early breast cancer at elevated risk of recurrence. This endorsement arises from the pivotal phase III NATALEE

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